- Data entry and validation
- Discrepancy Management
- Clinical data surveillance
- Protocol deviations review
- Serious Adverse Event (SAE) reconciliation
- External and third party data reconciliation
- Quality control
- Database Lock & Freeze
- ePRO, eCOA and device data integration
- SAS and SQL programming
- Data mining and migration
- CDISC SDTM standards
- MedDRA/WHODrug coding
- Risk based monitoring
- TMF Support & Documentation
- Submission and DM representation in inspections and audits
- Vendor management
- Project management and Data management oversight
Meet Frank, Evangelos, Faiyaz and Jens (read more below the picture). Furthermore, we cooperate with a large number of freelance consultants.
Senior Data Manager with more than 17 years of experience within the pharmaceutical industry.
Clinical Data Manager experience encompasses; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, user acceptance test, system validation, standard procedures, laboratory data, data import/export, coding procedures, CDISC SDTM standards, risk-based monitoring and data management oversight.
Experience with the following systems; Rave, eDM, eClinical, TrialMaster, Target eCRF, eStudio, QlikView, QlikSense and Microsoft Office.
Holds experience as both employed Data Manager and outsourced consultants in larger pharmaceutical companies as well as biotech. Have performed data management tasks in all phases (1-4) of clinical trials from start-up to closure and have an overall introduction and experience in the field.
Educated in IT engineering with a major in data science and started professional career as a Data Manager in a multinational company. Was quickly exposed to the complexities of drug development and enjoyed a variety of fast-paced Project Management roles. With years of experience contributing to successful regulatory submissions, joined Global Marketing as a Global Project Manager to expand knowledge and strengthen understanding of the Pharmaceutical Value Chain.An international background, having lived in Greece, France, USA, India, and Denmark and experience with the following systems: Microsoft Office, Adobe InDesign, SAS/R, SQL, Oracle Clinical, eDM, eClinical, Trial Master.
Clinical Data Manager experience encompasses; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, riskbased monitoring and data management oversight.
Domain expertise consists of Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM), data migration, CDISC SDTM standards, Risk Base Monitoring, SAE reconciliation and submission to Health Authorities with major pharmaceuticals.
Instrumental in change management from one EDC system to another EDC system. Managing resources, budgets, meeting stringent timelines of deliverables, harnessing opportunities (Risks/issues) primarily forms part of my work profile.
Hands on experience of Study Set-up, maintenance and Closure activities on various Clinical Database Management system – Oracle Clinical 5.2, Medidata RAVE, InForm 6.1, Central Designer 6.2, Clintrial 4.4, SAS and SQL programming.
Have worked on 7+ Molecules in Diabetes, Oncology, Obesity and Cardiovascular Therapeutic Areas. Overall knowledge of drug development process, Clinical research, GCDMP and Regulatory activities. Knowledge of Industry Regulations – ICH GCP, 21 CFR Part 11 (ERES) and GDPR.
Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.
Experience with the following systems; Microsoft Office, Framemaker, SAS, Oracle Clinical, eDM, eClinical, TrialMaster, Target eCRF, eStudio, Marvin, QlikView, QlikSense.
Experience with numerous therapeutic areas including; cardiology, gastroenterology, hematology, rheumatology, oncology (incl. first in human), endocrine & metabolic disorders and trauma.
Read more on the team and services here